Roots of Concern with Nonhuman Animals
in Biomedical Ethics
Lisa Sideris, Charles McCarthy, and David H. Smith
I
ntellectual debates over morality are one thing; policy
formation is another. Sometimes there are clear correlations between law or policy and ethics, but that is the
exception rather than the rule. Policy represents a response to
pressure, interest, and public opinion as much as—if not
more than—a deposit of community moral wisdom. Or is
this dichotomy so clear? Perhaps a policy can be both politically pragmatic and morally wise. US policy and ethics concerning uses of animals in research illustrate the separation
and complex connections among these levels of normative
thought. This article will trace a selective and brief history of
the movement to improve the treatment of animals involved
in research, explain why that movement was largely ignored
throughout most of the biomedical ethics revival of the last
decades, and show the convergence of these currents in the
development of US policy and regulations—although not in
bioethics as a whole—over the past 25 yr.
Concern for the Welfare of
Animals to the 1960s
British Origins
American animal rights and welfare movements have their
origins in British antivivisection societies. Although animal
experimentation had been conducted for centuries, it was not
widespread until the nineteenth century. Before the discovery of anesthesia in 1846, all animal experimentation was
conducted without any pain-relieving measures. Even after
the advent of anesthesia, vivisection was often performed
without palliatives of any kind, sometimes in flagrant violation of humane policy (Orlans 1993). The belief that animals
did not feel pain (owing in part to the legacy of Cartesian
dualism that viewed animals as automata) persisted through
much of the eighteenth and early nineteenth centuries. However, Jeremy Bentham (1748-1832) and later utilitarian
philosophers—notably John Stuart Mill (1806-1873)—put
the issue of pain at the center of their moral philosophy and
proposed legal reforms for animal protection. Bentham and
Mill believed that if animals could experience and anticipate
Lisa Sideris is a Ph.D. candidate in Religious Studies at Indiana University,
Bloomington, Indiana. David H. Smith, Ph.D., is Director of The Poynter
Center for the Study of Ethics and American Institutions at Indiana University in Bloomington. Charles R. McCarthy, Ph.D., is with Georgetown
University, Washington, D. C.
Volume 40, Number 1
1999
pain, they deserved moral consideration regardless of any
other apparent differences between humans and animals.
Bentham summed up his argument in a passage cited repeatedly by animal advocates today: "The question is not, can
they reason? nor, can they talk? but can they suffer?"
(Bentham 1789).
Long before organized opposition to cruelty to animals
arose in England, the British had earned the reputation of
being animal lovers—a "nation of pet-keepers," as one
London magazine quipped. (See Harriet Ritvo's important
discussion of the British tradition of pet-keeping [Ritvo
1987].) The widespread practice of pet-keeping moved the
British public to regard the use of vivisection as problematic
at best.
British legal action to protect animals began with the
passing in 1822 of the Act to Prevent Cruel and Improper
Treatment of Cattle or "Martin's Act," after Richard Martin,
who introduced the bill in the House of Commons. The act
originally covered only large domestic animals, but it was
amended in 1835 to include (as "cattle") bulls, dogs, bears,
and sheep and to prohibit bear-baiting and cock-fighting.
Between its founding in 1824 and the end of the century, the
Royal Society for the Prevention of Cruelty to Animals
(RSPCA1) was instrumental in supporting legislation to protect animals, creating shelters and veterinary hospitals and
arguing for more humane transportation and slaughter of
animals. Wild animals were generally not a focus of Victorian
reforms, nor was the abolition of vivisection a primary or
consistent priority of the Society; and some of its members,
notably feminist and animal activist Frances Power Cobbe,
soon left its ranks to oppose vivisection more directly. The
practice of vivisection was particularly important to those
favoring medical research. The Cruelty to Animals Act of
1876 established yearly licensing requirements for all experimenters and restrictions on experiments involving extreme
pain or unnecessary duplication (Finsen and Finsen 1994;
Guither 1998).
'Abbreviations used in this paper: AAALAC, Association for Assessment
and Accreditation of Laboratory Animal Care; AHA, American Humane
Association; ALDF, Animal Legal Defense Fund; ALF, Animal Liberation
Front; APHIS, Animal Plant Health Inspection System; ASPCA, American
Society for the Prevention of Cruelty to Animals; AWA, Animal Welfare
Act; Guide, Guide for the Care and Use of Laboratory Animals; IACUC,
institutional animal care and use committee; ILAR, Institute for Laboratory
Animal Research; NIH, National Institutes of Health; OPRR, Office for
Protection from Research Risks; PETA, People for the Ethical Treatment of
Animals; PHS, Public Health Service; RSPCA, Royal Society for the
Prevention of Cruelty to Animals; USDA, US Department of Agriculture.
The RSPCA was not the only active organization.
Socialist and animal advocate Henry Salt, aiming to promote the idea of "kinship of all sentient life," formed the
Humanitarian League in 1891 (Ryder 1989). Salt and his
followers meant to dispel the notion that concern for animals
was simply a sentimental (and feminine) preoccupation—a
common characterization, due to the largely female leadership of animal welfare groups. In 1911, animal cruelty legislation was consolidated under the Protection of Animals Act,
which raised fines for "cruelty and prohibited cruelty to any
bird, beast, reptile or fish," with the exception of animals
wounded and killed in bloodsports (Ryder 1989, p 131).
Why should Victorian Britain have turned its attention to
the suffering of animals with such vigor? The Victorian era,
which included the abolition of slavery and the rise of
women's movements and animal protection groups, appears
to have been a time of heightened sensitivity to pain (Turner
1980). The extent to which Darwin's theory of evolution
focused British attention on the suffering of their animal kin
is debated. In particular, Darwin's The Descent of Man and
Selection in Relation to Sex (1871) and his Expression of the
Emotions in Man and Animals (1872) emphasize the continuity of humans with the animal world. However, a "survival of the fittest" reading of Darwinism might appear to
legitimize human domination of the lower animals; Darwinism sent mixed messages. Cobbe, for instance, eagerly embraced the implications of Darwinism for better treatment of
animals, although she found the implications for human
morality shocking (Cobbe 1895). If nothing else, Darwin's
work appeared at a time when many people in England had
begun seriously to reconsider their dealings with animals.
Horror at vivisection may also reflect an anxiety over the
role of science in society and an increasing concern over a
loss of compassion among medical professionals (French
1975).
As World War I approached, animal movements, particularly antivivisection, began to lose their force. Moreover,
medical advances that had been made possible by animal
testing were occurring. Diphtheria and cholera antitoxins as
well as anthrax and rabies vaccines all were tested on animals. At the same time, Darwin's work was increasingly
becoming associated with eugenics and reactionary nationalism. Although there remains some debate over whether
advances in medicine are attributable to animal research or
whether they were simply due to improvements in public
health standards and sanitation, the connection between
medical progress and use of animals in research was firmly
established in the public mind (Sharpe 1988).
Animal welfare and rights groups made little headway in
the United Kingdom from the 1920s until the 1960s and -70s,
when the RSPCA was revitalized by Richard Ryder. Ronald
Lee and Clifford Goodman formed the Animal Liberation
Front (ALF1) in England in 1972. We discuss the work of
these organizations below (see University of Pennsylvania
Baboons).
American Pursuits
America lagged slightly behind Britain in organizing animal
movements. Although Puritan Nathanial Ward proposed two
provisions for animal protection prohibiting "tyranny or cruelty" to cattle in 1641 in the Massachusetts Bay Colony
(Finsen and Finsen 1994, p 42), it was only after the 1822
Martin's Act was passed in Britain that animal welfare movements began to take shape in America. In 1829, New York
State passed a law making cruelty to large domestic animals
(horses, oxen, and other cattle) a misdemeanor; a similar law
was passed later in Massachusetts. After visiting the RSPCA
in London, Henry Bergh decided to organize an American
anticruelty society in 1866 (Finsen and Finsen 1994). The
American Society for the Prevention of Cruelty to Animals
(ASPCA1) devoted much of its attention to the treatment of
work animals in cities, and Bergh soon gained a reputation
for enforcing anticruelty statutes in person whenever he witnessed horses being overworked or beaten in New York City
streets.
In 1868, a New England horse race between two trotters
named Empire State and Ivanhoe resulted in the deaths of
both horses, after they had been driven to the point of collapsing (Carson 1972). George Angell, a Boston attorney,
was outraged. Within a month, Angell had founded the
Massachusetts Society for the Prevention of Cruelty to
Animals. The Massachusetts group launched the publication
of Our Dumb Animals (MSPCA 1868), the first periodical in
the world concerned with the treatment of animals. The periodical carried stories about exceptional dogs and cats, published antivivisection essays, and produced investigative
pieces on the unsanitary and inhumane conditions of slaughterhouses. Other anticruelty societies began to appear in the
next few years, and by 1877, local and state animal protection groups became federated as the American Humane
Association (AHA1).
As in Britain, some animal advocates in America became
increasingly concerned with the practice of vivisection, but
attempts to pass legislation prohibiting vivisection met with
even less success in America than in the United Kingdom.
Antivivisection bills in the US Congress failed in 1866 and
again in 1880. Those who saw vivisection as the chief evil to
be eradicated became convinced, as Cobbe had in England,
that anticruelty societies were not doing enough about the
issue. Caroline Earle White founded the first antivivisection
society in America in 1883.
The medical and scientific communities were prepared
to fight back. In fact, the rise of antivivisection movements
appeared only to galvanize the opposition. The National
Academy of Sciences and the American Medical Association successfully opposed an 1896 bill calling for regulation
of vivisection. By 1908, animal researchers had formed a
Council on Defense of Medical Research with the objective
of securing the future of animal research in America. The
Council published and distributed pamphlets, arguing for the
WAR Journal
benefits of animal research and maintaining the ability of
animal researchers to regulate themselves (Finsen and Finsen
1994). As in Britain, animal researchers pointed to the recent
strides made in curing and controlling disease. Antivivisectionists attempted to disarm provivisectors by arguing
that cruelty to animals weakens one's moral character and
leads to cruelty toward humans; the medical community
countered that antivivisectionists were indifferent to human
suffering and stood in the way of scientific progress (Finsen
and Finsen 1994). Thus, lines of debate were drawn that
continue to be discernible in the current controversy over the
use of animals in research.
Movements supporting the humane treatment and welfare
of animals—as distinct from the antivivisection agenda—
continued to make some progress in the early part of the 20th
century, and by 1907, every state had some anticruelty
statute. On the whole, however, the years between 1920 and
1960 were characterized by little or no increased protection
of animals. This period of "stagnation," as Ryder calls it, was
exacerbated by an almost exclusive concern in the AHA and
ASPCA with the care of stray cats and dogs (Ryder 1989).
Laboratory animals, farm animals, and wild animals remained virtually neglected. (Some progress was made in
1958 with the passing of the Humane Slaughter Act, which
regulated the killing of food animals.) The AHA and ASPCA
did not endorse, and often opposed, antivivisection. In fact,
in the 1950s, the ASPCA was involved in the sale of pound
animals to laboratories for purposes of experimentation
(Finsen and Finsen 1994). The horrors involved in two world
wars did not help antivivisectionists; for many who had witnessed the human devastation of war, concern for animal
pain appeared "faintly ridiculous" (Ryder 1989). Whatever
the reason, at a time when the volume of animal experimentation was increasing dramatically, the use of animals in research was virtually unchallenged. In the period after World
War II, the practice of factory farming was also becoming
the modus operandi in American agriculture. The conditions
of animals in agriculture, laboratories, and the wild would
not improve significantly until the 1960s, when concern for
animals—and the environment as a whole—once again
gained momentum.
Biomedical Ethics
Concern for animal welfare and biomedical ethics surged in
the 1960s and early -70s, but their agendas were very different. There are at least two explanations for this fact, one of
which is human finitude. The specific issues that comprised
the agenda of biomedical ethics (such as respect for human
subjects in research, care for the dying, and changes made
possible by new technologies related to reproduction and
genetic research) presented a sufficiently rich social and intellectual set of problems in themselves. The scholar's ability
to be a generalist—keep abreast of all these issues and still
Volume 40, Number 1
1999
add others to the agenda—was limited. Insofar as scholarly
work was driven by a desire for social reform, bioethics
groups were made up largely of persons whose interests lay
elsewhere.
Beyond the fact that moralists have limited ranges of
interest and competence, there is another reason that concern
with nonhuman animals was not central to bioethics: It did
not fit well with the dominant intellectual paradigms driving
the development of the field. Indeed, it still is something of a
misfit.
The first two major influential discussions of bioethics in
the second half of the twentieth century were Joseph
Fletcher's Morals and Medicine (Fletcher 1954) and Paul
Ramsey's The Patient As Person: Explorations in Medical
Ethics (Ramsey 1970). Writing in the 1950s, Fletcher argued
against what he called "physicalism," and he was highly
critical of traditional Roman Catholic natural law theory. He
supported personalism—the idea that the central thing about
a human being was the capacity to think and have feelings.
We are most truly ourselves, Fletcher suggested, when we
are most in control, most rational. Thus, he could argue that
human beings lacking those capacities of thought were less
than fully human. Obviously, that view was controversial
since it challenged common notions of equal human rights.
Fletcher was either praised as someone willing to empower
rational decision making or criticized for insensitivity to the
needs and problems of the weak, impaired, and needy.
What did not get much attention was the fact that Fletcher's
focus on the rational decision making capacities of some
humans had the effect of devaluing not only nonrational
people, but also nonhuman animals. Fletcher's reformist
motivation focused so sharply on the need to empower people
that he never developed a set of concepts that enabled him to
explain how and why animal pain and distress mattered.
Indeed, it would have been risky for him to have developed
those concepts, for it would have forced him to concede the
relevance of those same kinds of noncognitive feelings or
factors in assessing the status of nonrational humans.
Ramsey's argument and perspective were more subtle
(Ramsey 1970), but the dominant theme in his work led to
the same conclusion. The Patient As Person: Explorations
in Medical Ethics begins with a chapter on experimentation
with human subjects in which Ramsey developed a highly
individualized and literalist view of the requirement of informed consent. Risk or injury to the human research subject
was not the fundamental issue, he argued. Rather, the whole
issue of the legitimacy of an experiment turned on whether
this specific subject has consented to the experiment. Children, who cannot consent on their own behalf, cannot be
legitimate research subjects if the research is not arguably
for their benefit. Risk and benefit mattered, he conceded, but
they were not the core of the issue. He held that research is
made legitimate when the subject becomes a "partner" with
the researcher, and partnership is impossible without consent.
Ramsey clearly was troubled by his own focus on the
conscious and deciding subject. In Chapter 4, he carried out
a lengthy "thought experiment" about a father who wanted to
donate his heart to his son; the donation would kill the father
(Ramsey 1970, p 188). Ramsey wanted to resist the idea that
consent was enough to make such an act right. However, the
focus on the knowing, rational self continues throughout the
book, including Ramsey's discussion of care for the dying.
In that discussion, he opposed active euthanasia as a form of
pushing someone beyond reach of care. Yet he allowed active
euthanasia if the patient were totally comatose, that is, if the
difference between remaining within reach of human care
and dying were irrelevant to the patient.
Ramsey pulled back from these exceptions in his later
work (Ramsey 1978), becoming highly skeptical of the "death
with dignity" movement. His emphasis on the importance of
embodiment is clear in his discussions of abortion. His view
was more complex than Fletcher's, but he led with the focus
on the consenting person. Moreover, his discussions of the
role of the body were focused distinctly on human bodies,
and his argument proceeded from the assumption of the worth
of the human self to an insistence that selves were embodied
and that their "pre- or postrationality" bodies mattered.
Nevertheless, there is little basis in Ramsey's work in
bioethics for concern for the welfare of nonhuman animals.
He could consistently have developed an animal welfare
ethic, but he did not, and it was not a natural part of his
intellectual trajectory that was targeted on loyalties and betrayals among human beings.
Biomedical ethics has changed and developed in many
ways in the 25 yr since Ramsey and Fletcher were among its
leaders. However, the focus on care for humans—treating
them with respect and justice—has continued to drive the
field. The acme of this deontological preoccupation with
human rights and dignity was probably H. Tristram
Engelhardt, Jr.'s The Foundations of Bioethics (Engelhardt
1986) in which the whole argument is based on the importance of respect for the autonomy of each individual conscious agent. Even thinkers whose methodological starting
point was self-consciously eclectic, as evidenced in the several editions of Tom L. Beauchamp and James Childress'
Principles of Biomedical Ethics (Beauchamp and Childress
1983), made the principle of respect for persons central and
were primarily concerned with the abuses of persons that can
occur when well-intentioned compassion runs amuck.
Although some aspects of biomedical ethics such as the
notion of embodiment and a relationalist/personalist paradigm could have been a basis for urging reform in the care of
laboratory animals, the emphasis on moral terms such as
autonomy, consent, and rationality excluded animals at the
outset. As mentioned above, Fletcher's understanding of personalism stressed the capacity of humans to think. However,
the term "personalism" connoted more than this to some
ethicists, particularly those within Roman Catholic theology.
The embrace of personalism over physicalism signaled for
them a greater valuation of the personal and interpersonal
meaning of physical acts such as sexual intercourse. Biological function was deemphasized, and greater consider-
ation was given to the broader social context in which physical life and acts unfold. This move in Roman Catholic moral
theology2—away from emphasis on the analysis of specific
physical acts and toward a more personalist perspective—
foreshadowed the changing attitudes toward laboratory animals in recent years. A preference for "performance standards" (discussed below) over mechanical or engineering
standards for evaluating the health and well-being of laboratory animals involves a recognition that their well-being
entails more than a suitable physical environment. Performance standards emphasize an animal's behavior with other
animals and with humans as an important indicator of its
overall well-being.
A connection between biomedical ethics and treatment
of laboratory animals could have been made here—between
personalism/relationalism and performance standards, both
of which are concerned with more than physical life. However, no such parallels were drawn because the dominant,
more individualist personalism made autonomy and rational
decision making central. Additionally, the concept of rights
has found a place in medical ethics as well as in animal
advocacy. However, the deontological slant of a position
such as Englehardt' s made his work an unlikely starting point
for the inclusion of animal rights in biomedical ethics. Although some animals may appear to have rational abilities,
most animal advocates would not single out rationality as a
defining feature. If animals have rights, the basis of those
rights must lie elsewhere than with their rational capacities,
autonomy, and ability to consent.
Concern for Animals from the Mid-1960s
The moral status of animals once again became a topic that
focused serious discussion in America in the 1960s and -70s.
A number of developments outside the field of bioethics
generated greater concern for animals during these years. In
1964, Ruth Harrison published Animal Machines, highlighting the often abominable living conditions of animals in factory farms. The study of both ecology and ethology in the
1960s reinforced a concern for the welfare of animals. Jane
Goodall's work with chimpanzees and gorillas (Goodall
1967, 1971) underscored human kinship with primates and
called attention to the need to protect them. In 1962, Rachel
Carson's Silent Spring (Carson 1962) warned of species
destruction and an almost apocalyptic aftermath of the widespread use of pesticides, particularly DDT. Environmental
organizations such as the World Wildlife Fund and
Greenpeace were founded in 1961 and 1969, respectively.
The latter, initially a conservation and antinuclear group,
gradually widened its scope to include animal protection as a
major priority. In 1969, the Endangered Species Act gave
some protection to wild animals. Concern for animals in the
wild and in factory farms probably contributed to an increas2
For an account of this paradigm shift in Catholic theology, see James
Gustafson's Protestant and Roman Catholic Ethics (Gustafson 1978).
ILAR Journal
ing awareness of the ethics of animal research; yet, as discussed below, the environmental movement in particular has
often shared an uneasy relationship with proponents of animal rights and liberation.
In addition to these important developments, the civil
rights movement of the 1960s unleashed powerful cultural
forces leading to protection of animals. Civil rights activists
began to see parallels between gender- and race-based discrimination, on the one hand, and ill treatment of animals, on
the other. Peter Singer in Animal Liberation (Singer 1975,
1990) popularized Richard Ryder's term, "speciesism": discrimination against nonhuman animals simply because they
are of another species when that fact is irrelevant to the value
at stake (such as pain and suffering). One example of the
close connection between civil rights and concern for animals
is the work of Henry Spira. After taking a course from Peter
Singer at New York University, Henry Spira, a civil rights
worker, turned his attention to what he believed to be a clear
and indefensible example of speciesism—experimentation
on animals. With the help of the Freedom of Information Act
(a real boon to animal activists in America), Spira obtained
detailed accounts of a series of experiments being conducted
at the Museum of Natural History's cat laboratory. These
experiments, aimed at discovering clues to sexual activity,
involved blinding, deafening, and removing part of the brains
of domestic cats. With the support of then-Congressman Ed
Koch, Spira's efforts resulted in the withdrawal of National
Institutes of Health (NIH1) funding and the subsequent dismantling of the cat laboratory in 1976-1977.
In the 1980s, a group calling itself the People for the
Ethical Treatment of Animals (PETA1) was formed by Alex
Pacheco and Ingrid Newkirk. In 1980, Kenneth Shapiro
organized the group Psychologists for the Ethical Treatment
of Animals (PsyEta); and in 1984, the Animal Legal Defense
Fund (ALDF1) was formed by attorneys and law students.
The ALDF has taken on cases involving the legal status of
laboratory animals, veal calves, and even wildlife.
Popular opinion has often tended to draw a definite line
between persons who defend animal rights and the liberation
of laboratory animals, and who are opposed to any use of
animals in research, and persons who advocate animal welfare protection and humane care and use of animals, but who
are not opposed to or who endorse the use of animals in
research. The distinction between those who recognize rights
in animals and oppose research and those who opt for animal
welfare and permit or endorse humane research may sometimes be useful, but it fails to describe accurately the positions taken by many leading contemporary philosophers.
Some of those who advocate animal rights, such as Jerrold
Tannenbaum, are fully supportive of the humane use of animals in research. Others, like Peter Singer, who does not
claim rights for nonhuman animals, are strongly opposed to
all or most research involving animal subjects. (For more on
this topic, see Russow [1999] in this issue.)
One of the foremost proponents of animal rights, Tom
Regan, argues that the central issue for evaluating the moral
status of animals is that animals must be recognized as "subVolume 40, Number
1999
jects of a life." They are not merely alive; they have lives.
Animals, Regan argues, are conscious beings with capacities
to desire, believe, and exhibit preferences; they entertain
goals and act deliberately. As such, animals not only have
intrinsic worth, they also share equal intrinsic worth with
humans.3
Utilitarianism, Regan argues, is not concerned with individuals' lives; however, true moral concern for animals is
based on a "radical egalitarian case for animal rights" (Regan
1994). Thus, Regan favors the total abolition of agribusiness,
hunting, and medical and commerical research on animals,
regardless of the benefits (great or small) to humans or the
amount of pain (great or small) to animals. In contrast to the
arguments of a utilitarian like Singer, animal rights are not
based solely on the experience of pain and suffering. Regan
and Singer reject speciesism, but on different terms.
Perhaps a more serious conflict in American animal
movements is that between animal activists and more holistic
conservation and ecology movements. Although movements
in ecology have fueled concern for animals in a variety of
contexts, these two groups are often at cross-purposes because they disagree about objectives. Animal activists view
the individual animal as the important issue; ecology-oriented
approaches aim at the preservation of a greater whole—a
species or ecosystem—occasionally at the expense of individual animal lives (see Donnelley [1999] in this issue).
Wildlife management may require sacrificing the lives of
members of an overrepresented species in an effort to sustain
the numbers of a threatened species or to prevent starvation
or malnutrition in the overpopulated species.
Indeed, an ecological perspective need not privilege sentience over nonsentience: Holmes Rolston notes circumstances in which sentient animals (in one instance, goats)
have been killed for the sake of preserving an endangered
plant species (Rolston 1994). In such cases, the integrity of
the ecosystem is given priority over the welfare of individual
animals. To many animal activists, the killing of large numbers of sentient animals appears cruel and senseless; to holistic environmentalists, however, the focus of many rights and
liberation arguments on the pain and suffering of animals
seems equally ill-conceived, even bizarre. Pain, they point
out, is not only necessary but even beneficial to the continuing survival and evolution of animal species. In particular, an
ethic revolving around the issue of pain cannot be applied to
animals in the wild. Although animal activists such as Singer
draw on a biological argument for human kinship with animals to challenge the speciesist status quo, the neoBenthamite account of pain as an evil to be eradicated remains "biologically preposterous" to some environmentalists
(Callicott 1995, p 53). The split between an ecological ethic
3
Regan acknowledges that not all animals possess the same level of consciousness, but he nevertheless maintains that all animals are subjects of a
life and therefore have inherent value. He does not understand differing
degrees of consciousness in animals as a basis for different treatment—
unless, that is, we are also willing to concede that humans with diminished
consciousness (infants, those with retardation, or those with some derangement) lack inherent worth.
and an animal rights stance has yet to be completely bridged
in America. Indeed, the question is often raised whether animal rights and liberation fall under the purview of environmental ethics at all (Sagoff 1993).
Traditional Judeo-Christian teaching on divine creation
has emphasized that only human beings, of all God's creatures, are made in God's image and likeness. Humans are
therefore understood to be superior to animals. The Genesis
description of Adam exercising the authority to "name" animals is typical of passages that are understood to mean that
God has given animals to humans for their use and discretion.
However, in the wake of criticisms of the Judeo-Christian
attitude toward animals (see especially White 1967), many
religious scholars have attempted to redefine the humannature relationship as one of stewardship and care, rather
than despotism or dominion. Humans' godlikeness has been
reinterpreted to entail a responsibility for trying to understand, care for, and order all of creation. According to this
interpretation, human creation in the image of God is understood as responsibility rather than license. Animals are not
given to us as subordinates but are to be celebrated as our
companions and partners in creation.
New Testament teaching, largely rooted in the Pauline
texts, calls for humans to "restore all things in Christ."
Aquinas understood Paul to mean that humans are to seek to
understand creation—and to glorify God, who has brought
all things into being. Creation comes from God (exitus) and,
through human understanding, returns to God (reditus).
Humans are seen to be high priests of creation, gathering all
beings and their interrelationships into human understanding
and praising the Creator who has given them being. In this
view, humans may use other creatures (nonhuman animals in
research, for example), provided they do so with awe, respect,
and constraint.
Some Christian writers have added another dimension to
the discussion—liberation theology. The argument of liberation theology is that at the end of time, animals as well as
human beings will be recipients of an eschatological peace
and will experience an end to their suffering. Drawing on
biblical writings (often the Isaiah and Pauline texts), Christian writers such as Charles Birch argue that Christians have
an obligation to aid in the liberation of nature from oppression and suffering (Birch 1990).
In this account, God's commitment to liberation and
welfare begins with humans but extends to the rest of the
animate creation. This expectation of a renewed creation
often has little in common with philosophical liberation arguments, such as Singer's, which rest largely on a biological
evidence of kinship. However, theological and philosophical
liberationists do partially concur in terms of their mutual
concern with eliminating the pain of animals; hence, both are
open to criticism from ecological ethicists who view this
concern as misguided.
Over the years, the lack of consensus among animal advocates of various stripes may have presented an obstacle to
any attempt to develop biomedical ethical theories applicable to both humans and animals. In developing an argu-
ment for the moral status and treatment of animals, whether
from a religious or secular perspective, some authors fail to
distinguish clearly (1) animals in the wild, (2) domestic animals, and (3) laboratory animals. It may be that a single
ethic cannot be applied to all. Until this issue is settled,
establishing a commonly held biomedical ethic that can deal
consistently with both animal and human research subjects
may remain out of reach.
Nevertheless, Peter Singer's work may be the best example of a coherent fusion of concern for the welfare of
animals with expertise in human biomedical ethics. A number of other academic authors—Tom Regan, Mary Midgley,
Michael Fox, and Bernard Rollin—have formulated arguments about human responsibilities to and for nonhuman
animals that should not be ignored, but Singer has melded
the two strands of social concern into a consistent whole. In
Practical Ethics (Singer 1993), he argued for consistency
across issues ranging from abortion and euthanasia to uses of
animals. Consistency is achieved by minimizing the suffering of sentient life, especially sentient beings who are aware
of their own past and future and might appropriately be called
persons. There are, he argues, nonhuman persons as well as
humans who are not persons. Needless to say these theses are
controversial, but arguments advanced by Singer and others
for them have successfully included animals as an inescapable element of the agenda of biomedical ethics. One symbol
of this fact is that entries related to animals comprise 49
pages in the second edition of the Encyclopedia ofBioethics
(Reich 1995;.
Regulation in This Changing Context
American regulation of the uses of laboratory animals in
research reflects this complex history. One point seems clear,
however: Changing attitudes toward treatment of laboratory
animals owe little to developments within the field of bioethics. As described below, public outcry over a few wellpublicized cases of the purported misuse of animals in laboratories appears to have had a very important impact on
changes in regulation. Changing perspectives in biomedical
ethics have underscored the importance of the changes in
rules and standards; but those changes were not ideologically
driven in the 1970s and -80s.
Beginning in 1963, NIH contracted with the Institute of
Laboratory Animal Resources (ILAR1, later renamed Institute for Laboratory Animal Research) of the National Academy of Sciences to offer guidance for awardee institutions
concerning the care, housing, and husbandry that should be
provided for vertebrate animals involved in research. NIH
and ILAR recognized that vertebrate animals involved in
research must be housed and cared for in a humane and
respectful manner, that research animals must be maintained
in a contented and healthy state if reliable scientific results
from their use are to be obtained, and that public support of
research involving animal subjects is contingent on the animals being treated in a humane manner.
ILAR Journal
On the basis of this contract, ILAR produced in 1963 the
first edition of the Guide for the Care and Use of Laboratory
Animals (Guide1) (NRC 1963). Updated regularly over the
years, the Guide is now recognized as a worldwide standard
for a laboratory animal care and use program. In 1966, the
Laboratory Animal Welfare Act was passed, requiring registration of all animal laboratories and licensing of all animal
dealers.4 In 1970, it was renamed the Animal Welfare Act
(AWA1) and expanded to include all warm-blooded species.
The Office for Protection from Research Risks (OPRR1)
played the key role in policy formation and enforcement, but
that role changed greatly over time. From 1963 to 1979,
OPRR's role in assuring animal welfare was for the most
part limited to education and persuasion of staff veterinarians in institutions that were awarded Public Health Service
(PHS1) grants. OPPR encouraged the hiring of diplomates of
the American College of Laboratory Animal Medicine—veterinarians with advanced training and experience who are
recognized as experts—to direct programs in the awardee
institutions. Furthermore, it encouraged, but could not require, institutions to seek accreditation from the Association
for Assessment and Accreditation of Laboratory Animal Care
(AAALAC1).5
The PHS Policy from 1963 and through the revision of
1979 was inadequate in many ways. Assurances of compliance signed by awardee institutions provided little detail beyond a statement that the institution intended to comply with
the recommendations in the Guide. Assurances did not make
it clear which senior institutional official would be held
responsible for compliance with the Policy. Furthermore,
assurances did not require prior review and approval of research protocols, and they required only minimal record
keeping. As a consequence, although the assurances required
in 1979 probably contributed in a small way to the improvement of care and use of animals, their impact was not great
(see also Dresser [1999] in this issue).
It was apparent that the quality of the animal programs in
most institutions depended primarily on the institutional veterinarians and their staffs. If the veterinarians were well
trained, given adequate resources, and allowed to exercise
authority over the housing, care, and use of the animals, then
the programs were compliant and strong. However, if institutional veterinarians lacked training, resources, or administrative support, their programs were usually weak. Many
veterinarians complained that they were cast in the role of
"research cops" who had obligations stemming from both
their veterinary oath and their responsibility under the PHS
4
The Animal Welfare Act of 1966 (PL 89-544) was amended in (1) 1970 by
PL 91-579, (2) 1976 by PL 94-279, and (3) 1985 by PL 99-198.
5
Formerly known as the American Association for the Accreditation of
Laboratory Animal Care, AAALAC International provides on-site visitation, evaluation, and assessment of the quality of the laboratory animal care
and use programs of its member institutions in the United States, Canada,
and Europe. AAALAC uses the Guide as its standard for evaluating the
quality of laboratory animal programs.
Volume 40, Number
1999
Policy and the AWA to see that animals were properly cared
for and humanely used in research.
Unfortunately, in many cases, veterinarians lacked administrative authority to insist that research investigators use
animals properly. In a typical research institution, tension
existed between research investigators who used animals for
their research and veterinarians who understood their role as
ensuring that animals used in research be well maintained
and experience as little pain or distress as possible. Many
institutions had no central vivarium; animals were housed in
convenient locations for research investigators. Department
heads or individual research investigators were, in most
cases, responsible for the animals involved in their research.
They usually were not trained to care for the animals. Staff
veterinarians were available for consultation, but many investigators failed to consult with their staff veterinarian because the cost of correcting problems might be charged to the
researcher's grant.
Between 1979 (when the PHS Policy was revised) and
1981, OPRR was preoccupied with responding to the recommendations of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research.
Staff energy was devoted primarily to efforts to incorporate
the recommendations of the National Commission into the
Department of Health, Education, and Welfare Regulations
for the Protection of Human Subjects. The sole veterinarian
on the OPRR staff retired, and hiring freezes prevented recruiting a replacement veterinarian. OPRR's program for
animal welfare was maintained but not improved during this
period.
After the Regulations for the Protection of Human Subjects were promulgated in 1981, OPRR began to improve its
oversight of awardee programs involving laboratory animals.
As soon as OPRR focused renewed attention on enforcement
of the 1979 Policy, the Policy's shortcomings began to come
to light. The Policy was vague regarding the level of detail
required in an assurance document, and assurance documents
were often brief. The Policy required animals to be maintained in a manner consistent with the recommendations in
the Guide but failed to require documentation of how that
was to be accomplished. The Policy did not require prior
review and approval of protocols by an institutional animal
care and use committee (IACUC1). For that reason, some
studies involved more animals than necessary to achieve
reliable scientific results. Inhumane procedures were sometimes carried out in the name of science. The Policy required
little record keeping, and it made no provisions for voluntary
reporting of problems associated with the care or use of laboratory animals. OPRR soon recognized that the Policy was
both flawed and extraordinarily difficult to enforce.
In 1982, OPRR began to gather information necessary to
revise and upgrade the PHS Policy. Until that time, the
Policy was endorsed by the authority of the Assistant Secretary for Health, who made compliance with the Policy a
condition of receiving an award to carry out research involving laboratory animals. Issuance of the Policy was not required by law, and Congress paid little attention to labora-
tory animals and the policies that governed their care and
use. Then a series of events attracted public attention. Two
cases in particular had a profound impact on the Policy. The
cases described below are an interesting illustration of the
fact that changes in policy regarding laboratory animals had
little relation to currents within the field of biomedical ethics.
Silver Spring Monkeys
In late summer 1982, Alex Pacheco, then a student at George
Washington University and a founder of PETA, took a summer
job in the Silver Spring, Maryland, laboratory of Dr. Edward
Taub. While Dr. Taub was away from his laboratory on
vacation, Mr. Pacheco arranged to have several veterinarians
visit the laboratory, which housed approximately 15
deafferented primates (that is, for each animal, the motor and
sensory nerves of one arm were severed). Dr. Taub was
studying regeneration of severed nerves. Mr. Pacheco took a
series of colored photographs of the condition of the animals.
Then he arranged for a state police raid on the facility under
the Prevention of Cruelty to Animals law of the state of
Maryland. The visiting veterinarians, the colored photographs, and the police report all alleged that the animals were
housed in a filthy, fetid environment that constituted cruelty
to the animals.
Dr. Taub claimed that his laboratory was clean and well
run when he left on vacation. He claimed that Mr. Pacheco
had trashed the laboratory, failed to clean cages, neglected
the animals, and subjected the laboratory to false reports of
animal cruelty. In response, Mr. Pacheco claimed that he
merely documented the deplorable state of the laboratory
and the condition of the animals. Initially the matter was
handled in the courts of Maryland. Dr. Taub was convicted
on six counts of animal cruelty, but a court of appeals set
aside the conviction on the grounds that since the laboratory
was subject to the PHS, the issue was a federal matter. The
court remanded custody of the animals to the NIH. OPPR
initiated an investigation.
OPRR was never able to determine with a high level of
confidence whether (1) Dr. Taub operated an abominable
laboratory, (2) Mr. Pacheco had trashed a well-run laboratory in Taub's absence, or (3) neglect by Taub and trashing
by Pacheco combined to create a dreadful situation. Taub
claimed that he had been "set up" by PETA in such a way
that he appeared to be in serious noncompliance with the
PHS Policy. Some of the facts in the case made such a defense plausible. For example, the prosecuting attorney for
the state of Maryland subsequently took an administrative
position with PETA. Furthermore, (1) the state temporarily
housed the animals, in violation of a number of city ordinances, in the basement of a Rockville house owned by Ingrid
Newkirk President of PETA; and (2) the animals were stolen
from the Newkirk residence—only to be returned with no
questions asked. These facts provide some circumstantial
evidence to support the contention that PETA had indeed set
up Dr. Taub.
10
Dr. Taub acknowledged to OPRR that his records were
intact. The records showed that the animals had not received
routine veterinary care for a period of years. Because the
animals were deafferented, they required more specialized
care than most other primates. Absence of veterinary care for
a period of years constituted a serious violation of the PHS
Policy. Taub's defense that he personally had provided care
for the animals was considered inadequate.
Dr. Taub's grant was suspended until such time as his
laboratory could be brought into compliance and he was able
to demonstrate that he could meet all the standards set forth
in the Guide. Taub appealed the decision but lost the appeal.
His laboratory was never restored, and the animals remained,
by court order, in the custody of NIH (despite a series of
lawsuits brought by PETA) for many years until all died or
were euthanized. Custody suits brought by PETA were taken
all the way to the Supreme Court, which confirmed decisions
of the lower court that PETA had no legal standing on which
to base its claim for custody of the animals. The "Case of the
Silver Spring Monkeys," as it was called in the media, lasted
for a period of approximately 10 yr.
University of Pennsylvania Baboons
In 1983, another case gained national headlines. A group that
identified themselves as the Animal Liberation Front broke
into the University of Pennsylvania Head Injury Clinic in
Philadelphia. Equipment was smashed and files were scattered. Most important, approximately 60 hr of audio/videotapes were stolen. Research investigators had used the tapes
to capture visual images of research animals—data concerning heartbeat, blood pressure, and brain wave activity—as
well as investigators' comments.
The protocol called for sedated baboons to be injured in
a machine that simulated the "whiplash" motion that often
inflicts damage to the neck and spine of humans involved in
rear end auto crashes. The nature of the animals' injuries was
to be studied, and the animals' unassisted recovery from
injury was to be compared with the recovery of animals that
received a variety of treatment modalities. The protocol was
controversial because it required the infliction of a severe
injury on the baboons. Each animal, ultimately, would be
examined in terminal surgery.
ALF gave the stolen audio-/videotapes to PETA. PETA
edited the tapes, added a "voice-over commentary," and circulated the edited tape entitled Unnecessary Fuss6 to schools,
newspapers, television networks, dozens of television stations—and Congress. Congress and members of the general
public were shocked at the cruelty to and disregard for the
research animals presented on the tape. PETA then petitioned the PHS to close the laboratory and punish the inves6
The title Unnecessary Fuss was derived from a statement by Dr. Weingarden, then Director of NIH, regarding an "unnecessary fuss" made by
ALF and PETA over research involving animals—particularly that conducted at the Head Injury Clinic at the University of Pennsylvania.
WAR Journal
tigators, Drs. Langfit and Genarelli, for violation of the PHS
Policy.
OPRR refused to act on the basis of evidence contained
in an edited tape. The University of Pennsylvania claimed
that Unnecessary Fuss was a caricature of the actual proceedings that had taken place in the laboratory. For more
than 1 yr, PETA refused to turn over the evidence it had to
OPRR. In the spring of 1984, PETA sent the unedited tapes
to the US Department of Agriculture (USDA1), which in turn
sent them to OPRR. OPRR asked 18 veterinarians, mostly
diplomates of the American College of Laboratory Animal
Medicine, who were for the most part employed by various
institutes within NIH, to review the tapes and report on their
findings concerning violations of the PHS Policy or the
AWA. In the meantime, OPRR conducted several site visits
to the Head Injury Laboratory. On the last of those site visits,
Dr. Genarelli performed a surgical procedure that he claimed
was typical of those involved in the study. OPPR was astonished to learn that asceptic technique was sloppy, that smoking was allowed in the operating theater (improper on many
grounds, and a dangerous procedure where oxygen tanks are
stored and used), that the depth of induced anesthetic coma
in the animals was questionable, and that most of the animals
were not seen by an attending veterinarian either before or
after the injury.
However, OPRR discovered that Unnecessary Fuss presented the case history of only one of approximately 150
animals that had received whiplash. By clever editing and
inaccurate voice over, the viewer was led to believe that the
inhumane treatment depicted on the film was repeated numerous times. In actual fact, one baboon was badly treated,
and the film repeatedly showed the particular mistreatment
while the commentator narrated that the mistreatment was
repeated on a long series of different animals. In all, OPRR
identified approximately 25 errors in the voice over description of what was taking place. Typical was the statement
accompanying an accidental water spill that acid had been
carelessly poured on a baboon.
Despite the fact that Unnecessary Fuss grossly overstated
the deficiencies in the Head Injury Clinic, OPRR found many
extraordinarily serious violations of the Guide. Veterinary
and posttrauma nursing care for the animals was inadequate,
surgical techniques were not carried out in the required aseptic manner, the operating theater was not properly cleaned,
the holding facility lacked the required number of air changes
per hour and other features required of a holding facility, and
occupational health safeguards were not enforced. Furthermore, OPRR found deficiencies in the procedures for care of
animals in many other laboratories operated under the auspices of the University of Pennsylvania.
The University of Pennsylvania was put on probation by
OPRR. The Head Injury Clinic was closed. The chief veterinarian was fired, the administration of animal facilities was
consolidated, new training programs for investigators and
staff were initiated, and quarterly progress reports to OPPR
were required.
Although OPRR dealt with a small number of additional
Volume 40, Number
1999
cases of violation of the 1979 PHS Policy for the Care and
Use of Laboratory Animals, the cases of the Silver Spring
Monkeys and the University of Pennsylvania Head Injury
Clinic were the two events that caught the attention of the
public and Congress, illustrated the serious weaknesses in
the 1979 Policy, and focused the attention of the Assistant
Secretary for Health and the Director of NIH on the importance of upgrading the PHS Policy.
As a result of these cases and heightened public sensitivity, OPRR took three major steps to upgrade the Policy for
Humane Care and Use of Laboratory Animals. First, it convened a committee drawn from across the PHS to provide
advice. Second, it persuaded Congress (particularly Congressman Doug Walgreen) to postpone legislation long
enough for the new Policy to be promulgated and tested.
Third, it initiated a series of educational workshops that were
presented in every region of the country as well as to NIH
staff. The proposed Policy was widely tested and discussed,
and public comments were elicited.
The PHS committee that drafted the new Policy was
aware of the fact that a large majority of citizens supported
the responsible conduct of biomedical research involving
animals. However, that same majority opinion was strongly
opposed to inadequate care for laboratory animals and was
anxious to minimize the distress in these animals. After
considerable discussion, the PHS committee concluded that
IACUCs—patterned after institutional review boards, which
had provided protections for human research subjects for
nearly 20 yr—were needed. Furthermore, the PHS committee concluded that if IACUCs conducted prior review of each
protocol proposing to involve laboratory animals, then animal pain could be minimized. Because IACUCs would be
required to keep accurate minutes and records, they could
provide accountability to the public that research was conducted according to the criteria described above.
The PHS committee was aware that there existed no consensus—among scholars, the research community, or the
public—supporting a comprehensive biomedical ethic of research involving animals. The PHS committee was unable
to provide IACUCs with a widely held ethical framework
comparable with that outlined in the Belmont Report, which
identified principles to be used in evaluating research involving human subjects.
The creation of IACUCs to review research involving
animals was therefore an act of faith that IACUC members
would gradually develop the ethical principles and standards
needed to provide the intellectual framework for evaluating
research involving animals. Most IACUCs have developed
an "ethical scale" for evaluating protocols. The scale states
that pain and distress inflicted on laboratory animals can be
justified only by the quality and importance of the scientific
objective of the study. Intense and prolonged pain can rarely
be justified, and then only if the science is elegantly designed
to obtain important knowledge that can be obtained in no
other way.
The revised PHS Policy was promulgated in May 1985.
Promulgation of the Policy was coordinated with the publi11
cation of the 1985 version of the Guide (NRC 1985), edited
and published by ILAR. The new Policy included many new
provisions of which the most important new requirements
were
1. requiring each assured institution to identify, both by
name and office, the "institutional official" to be held
responsible for assuring that the institution's laboratory
animal program would meet or exceed the recommendations in the Guide;
2. establishing an IACUC in each awardee institution;
3. requiring semiannual inspection of all animal holding
facilities followed by a report to OPRR of all deficiencies in facilities, staffing, or training and steps taken to
remedy the deficiencies;
4. requiring an occupational health program including standard operating procedures for all persons who had contact with laboratory animals (a program designed to protect both human and animals);
5. requiring prospective and ongoing protocol review by
the IACUC and periodic reporting to OPRR with a special proviso for immediate reporting of serious problems;
and
6. beginning a system of evaluation based, at least in part,
on "performance standards," that is, judging the worth of
a program by the health of the animals and the speciesspecific behavior of the animals. The professional judgments of persons who attend the animals rather than technical compliance with requirements for cage sizes,
facility cleanliness, frequency of air changes, and so forth
were to be accorded significant weight.
These PHS policies were, in effect, enacted into general
law when the Congress enacted the Health Research Extension Act of 1985 (PL 99-158). The current Policy relies
almost entirely on hands-on experience rather than the literature that was beginning to come from the bioethics movement in the United States dealing with the moral status of
animals. The revised Policy—assisted no doubt by the strident, although often illegal and inaccurate, criticisms of the
animal activists—accelerated the development of programs
for the care and use of laboratory animals from a system that
was, at best, mediocre to one in which Americans may legitimately take pride. The 1985 PHS Policy represents an act of
trust that IACUCS would, over time, develop standards by
which to judge prospective protocols involving animal subjects. That act of trust has been fully justified. IACUCS
have examined virtually every procedure used by investigators and have evaluated virtually every system, method, and
technique for caring for animals and documenting that care.
One month after passing the Health Research Extension
Act, Congress incorporated amendments to the AWA in the
Food Security Act of 1985 (PL 99-198). The new law, which
was to be administered by the USDA, was detailed, complex,
specific, and internally inconsistent. Among its provisions,
the Act called "for exercise of dogs" and ensuring the "environmental enrichment" of primates. It also called for harmo12
nization of policies from the two government agencies
through USDA consultation with the Secretary of the Department of Health and Human Services.
Initially in 1987, USDA minimized the harmonization
clause and independently published proposed implementing
regulations. A storm of criticism greeted the proposed rules.
The USDA issued a revised proposal of regulations to
implement the amendments to the 1985 AWA. The second
set of proposed regulations met with criticism equal to or
greater than that raised by its predecessor. The criticism
reflected awareness on the part of the biomedical research
community that the flexible system promulgated by the PHS
Policy, which left important discretion to local IACUCs, was
successfully improving the care, and minimizing the pain
and distress, of animals. The research community was unwilling to endorse regulations that relied solely on engineering standards similar to those that had characterized earlier
USDA regulations. Thousands of angry letters were sent to
the USDA, to Congress, and to the White House protesting
the proposed regulations. The general theme of the letters
called for reduction of engineering standards and the adoption of performance standards in the new regulations.
Staff of the Animal Plant Health Inspection System
(APHIS1) of the USDA discussed the matter many times
with OPRR staff, and they jointly decided that a meeting
should be held between the Assistant Secretary for Health
and his counterpart from the USDA. Leaders from APHIS
and OPRR and lawyers from the USDA and the Department
of Health and Human Services participated in the meeting.
The historic outcome of that meeting was an agreement
to rely heavily on the clause in the AWA that called for
consultation between the two departments. OPRR and
APHIS agreed to "harmonize" the PHS Policy and the AWA
regulations as much as possible, consistent with the law.
APHIS and OPRR worked together to produce regulations
that introduced into USDA regulation performance standards
to be used instead of, or in addition to, engineering standards. The Office of Management and Budget, representing
the White House, welcomed the agreement and authorized
promulgation of the harmonized rules.
USDA regulations produced in 1991 met with instant
approval and endorsement from the research community, but
they were criticized by animal activists and challenged in
court by the ALDF. The ALDF won its case against the
performance provisions in the regulations dealing with dogs
and nonhuman primates in the lower court but was found by
the court of appeals to have no standing. The Supreme Court
refused to grant a writ of certiorai. A more recent suit resulted in standing being granted by the full District Court to
one individual who was harmed by observing treatment of a
nonhuman primate in a private zoo. At the time of this
writing, this case is being appealed to the Supreme Court.
The shift to a performance standard and the cooperation
among government agencies are particularly important efforts to ensure the welfare of animals used in research. In the
1970s and 1980s, the relationship between USDA officials
with responsibility for implementing the AWA and OPRR
ILAR Journal
staff was cool and distant. Rivalry, suspicion, and contrasting approaches to regulations characterized the relationship.
The USDA approach was overseen by its Office of General
Counsel and sought to produce rules that could be enforced
in court proceedings. Emphasis on standards that could be
easily measured, weighed, or documented characterized the
USDA rules. Until the 1985 amendments to the AWA, the
USDA's authority was confined to holding facilities for animals. It exercised little jurisdiction over the use of laboratory animals in research. USDA inspectors had been trained
to check such items as cage sizes, expiration dates on feed
bags, sanitation, air flow, clean water dispensers, thermostats, pest control, lighting, bedding, and cage washing. Because USDA chose not to exercise jurisdiction over rats and
mice (approximately 90% of all the animals used in research),
inspectors never visited research facilities that used only
those rodents.
Because there were so many items on the USDA check
list, virtually every institution failed to meet some USDA
standards. On Monday mornings, for example, most cages
are littered in most laboratories. Inspectors visiting a holding facility on a Monday almost always found sanitation to
be deficient because the cages had not been cleaned since the
preceding Friday. If a bulb had burned out, a cage washer
needed repair, a crack had formed in a wall or a ceiling
(which could possibly harbor vermin) even though it was
sprayed weekly with hot water and disinfectant, the institution could fail inspection. The standards were difficult to
meet and allowed important elements, such as the animals'
health and social interactions with others of their kind, to go
uninspected.
Under the new regulations harmonized with the PHS
Policy, all of these items are evaluated, but the primary evaluation is directed to the health of the animals. If the animals
exhibit normal behavior, eating habits, and social interaction, have good coats, are neither too thin nor too fat, have
been checked periodically by a veterinarian, are socialized to
other animals and to their human caretakers, then mechanical failures and floor cracks are not viewed by USDA inspectors as serious. In other words, the engineering standards are
viewed in the light of outcome or performance standards and
judged accordingly. Performance standards require better
trained inspectors who are qualified to evaluate animals.
Staff from the Division of Animal Welfare within OPRR
have worked closely with staff from APHIS to develop common standards for inspection and evaluation of animal facilities and practices. Because performance standards rely on
professional judgment, it is important for site visitors from
OPRR and inspectors from APHIS to reach an understanding
regarding how to implement the performance standards.
Although occasional disagreements and conflicts have surfaced, each disparity has been resolved between the two offices. Inspection teams from AAALAC have also adopted
interpretations of the regulations consistent with those of
APHIS and OPRR. Largely as a result of the harmonization
that was initiated in 1990, the management of animal facilities and the conduct of animal research have, by all accounts,
Volume 40, Number
1999
improved dramatically. As noted above, this shift to performance standards is consistent with the new emphasis on
social or interactive personalism in biomedical ethics. However, the move toward performance standards seems to have
occurred independently of changing currents within biomedical ethics that might have supported it, had biomedical ethics
explicitly widened its scope to include nonhuman animals.
Conclusion
Despite a relative paucity of interest on the part of scholars in
biomedical ethics, concern with the health, welfare, and (for
some) the interests of animals used in research has become
part of the agenda of biomedical ethics. Regulatory accountability for the welfare of laboratory animals in the United
States has improved steadily over the past quarter century
and dramatically since the late 1980s. Concern with animal
socialization and welfare reflects more generally ideas that
are important in biomedical ethics. Conflict between persons
and groups who differ on the legitimacy of doing any research on all (or classes) involving nonhuman animals can
be expected to continue. The practical and philosophical
issues involved are complex, and there is no general consensus on their resolution. However, there appears to be nearconsensus on the importance of maintaining the welfare of
research animals. Research animal welfare is dramatically
improved under the current policy and regulations.
There are a number of possible explanations for the fact
that concern with research animals was not a central part of
the biomedical ethics agenda from the beginning. Prevailing
paradigms in the field did not provide a natural starting point
for concern with animals. Preoccupation with the choices of
a rational subject leading to great concern with consent and
autonomy pushed a different agenda. Yet even for scholars
working from different philosophical perspectives, convergence between concern for animals and bioethics did not
occur. Singer's work is the best example to date of an effort
to establish an ethic that can be consistently applied to
humans in bioethics and to animals in research. However,
because Singer minimizes differences between the moral
status of humans and animals, his work is unlikely to provide
a synthesis that is acceptable both to the research community
and to its critics. An alternative comprehensive vision would
be welcome (DeGrazia 1991, 1996).
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